Camargo Preclinical Service
Camargo ensures the appropriate regulatory requirements are met every step of the way, streamlining your drug development process all the way to approval.Ready to guide you through the preclinical stage of drug development, Camargo provides strategic support in the following areas: CRO selection Study design Study setup and execution Project management In clinical program development, camargo's focus is unwavering:…
Camargo ensures the appropriate regulatory requirements are met every step of the way, streamlining your drug development process all the way to approval.
Ready to guide you through the preclinical stage of drug development, Camargo provides strategic support in the following areas:
- CRO selection
- Study design
- Study setup and execution
- Project management
In clinical program development, camargo's focus is unwavering: Move products from preclinical through to FDA approval as efficiently as possible. Using proven methodologies that can meet FDA guidance requirements and expedite the drug approval process while reducing overall study costs.
Experts develop a customized clinical program plan for each drug, which includes only the services necessary for preparation and hands-on implementation.
Also seasoned medical writers apply their proven research and investigation skills to design protocols that streamline the clinical trial process, reduce study costs and expedite the drug approval process. When protocol design is complete, Camargo's team moves from planning to implementation, all the while working in close partnership with your team.
Camargo Clinical Design Expertise:
- Bioavailability
- Bioequivalence
- Comparison
- Dose-ranging
- Drug interaction
- Drug metabolism
- Efficacy
- Patient preference
- Proof-of-concept
- Quality of life
- Radiopharmacology
- Safety
Identifying Products for Drug Development Programs
This white paper describes how the 505(b)(2) services offered by Camargo, can help pharmaceutical companies to identify and assist in the development of its 505(b)(2) candidate.
CMC for 505(b)(2) Applications
The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. This poster outlines the variations that can occur from application to application depending on the dosage form, drug product, and type of file under construction, specifically a 505(b)(2) application.
